Our Clinical Trials: Colorectal Cancer

March is Colorectal Cancer Awareness Month, and the GI Cancer Institute is joining people and organisations worldwide to raise awareness of colorectal cancer and the need for better treatments. The AGITG has eight clinical trials recruiting participants with colorectal cancer.

Find out more about these trials by clicking the links below, or scroll down for the latest news on our colorectal cancer trials.

First patient enrolled in RENO

The RENO study has activated its first site and the first patient has been enrolled in the study. RENO is a study in rectal cancer titled: ‘A Prospective Study of Watch and Wait Strategy in Patients with Rectal Cancer who have obtained a Clinical Complete Response with Concurrent Chemo-radiotherapy (REctal Cancer No Operation).

The study will examine whether some people being treated for rectal cancer can forgo surgery after chemoradiotherapy treatment. Surgery can have long-term side effects and many patients need permanent stoma construction. After their chemoradiotherapy treatment, participants with no signs of residual disease will be enrolled into the ‘Watch and Wait’ arm of the study. They will be carefully monitored for any sign of local recurrence during follow up reviews.

Rectal cancer is an area where more research is needed. Deaths from rectal cancer are expected to rise by 60% by 2035, according to a recent study published in the International Journal of Cancer.

If any sign of residual cancer is found after a participant completes chemoradiotherapy, they will be enrolled into the ‘standard management arm’ of the study and will proceed with standard management, including surgery.

Around 20% of patients develop an apparent complete response to chemoradiation. The aim of RENO is to demonstrate that at least 70% of these ‘clinical complete responder’ patients can preserve rectal anatomy and avoid major surgery without developing a local cancer recurrence. RENO’s Investigators aim to enrol a total of 250 participants – 50 in the ‘Watch and Wait arm, and 200 in the ‘Standard Management’ arm.

“It is incredibly exciting that RENO has opened to recruitment,” says Professor Chris Karapetis, Principal Investigator of RENO. “There is a gap in our knowledge when it comes to watching and waiting as an approach for rectal cancer.”

“I hope that this study will lead to a meaningful improvement in patient outcomes and guide future clinical practice for rectal cancer treatment.”

Better treatment for elderly patients with MONARCC Trial

Elderly patients with advanced colorectal cancer may soon have milder effective treatment options available to them, as a result of research being done in the MONARCC trial.

Colorectal cancer is most commonly found in patients over 50, and the average age of diagnosis is 70. All patients with advanced bowel cancer are currently treated with a combination of chemotherapy and an antibody treatment. However, previous trials that have studied the effects of this treatment have examined a young, fit and healthy population. This does not represent the typical patient population. Elderly cancer patients may not be able to withstand this treatment in the same way, or might wish to have different options available.

In the MONARCC trial, researchers are studying the potential of using a ‘lighter’ chemotherapy regimen, 5 flurouracil, together with the antibody treatment panitumumab. They will also test the effectiveness of using panitumumab by itself. These options could provide effective cancer control while minimising side effects.

The Principal Investigator of the MONARCC trial, Dr Matthew Burge, believes that it will be instrumental in providing “a treatment option for elderly patients that is well-tolerated, that’s convenient, and that provides them with the best outcomes in terms of survival and quality of life”.

MONARCC is open and has recruited its first patient. More information is available here.